FDA Grants Priority Approval to Hernexeos for NSCLC
WASHINGTON, D.C., February 26, 2026 The U.S. Food and Drug Administration (FDA) has granted approval to Hernexeos (zongertinib) for...
Accelerated Approval
Advertisement
OST-HER2 Regulatory Progress Advances Osteosarcoma Care
NEW YORK, NEW YORK, UNITED STATES — February 17, 2026 OS Therapies has announced a major global regulatory update...
FDA CRL Delays Bitopertin Approval for Rare EPP Disease
WATERTOWN, Mass., Feb. 13, 2026 — Disc Medicine announced that the U.S. Food and Drug Administration has issued a...
OS Therapies Gains Key FDA & EMA Milestones for OST-HER2 Immunotherapy
NEW YORK, NY — December 5, 2025 — OS Therapies Inc. announced two major regulatory milestones advancing its lead...
Vivace Therapeutics Gains FDA Fast Track Designation for VT3989 in Mesothelioma
SAN MATEO, Calif., October 8, 2025 — Vivace Therapeutics, Inc., a biotechnology company pioneering small molecule cancer therapies that...
Advertisement
